StrokeNCT05901909

Training Given to Caregivers of Stroke Home Care Patients.

A study testing Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients in people with Stroke, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 13 Jul 2023to 18 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals who care for semi-dependent or fully dependent stroke home care patients who agree to participate in the study,
No communication problems,
Do not have any psychiatric disorders that will reduce the ability to comprehend and understand,
Caregivers over the age of 18.
Semi-dependent or fully dependent stroke home care patients,
Adult patients,
Patients whose legal guardians or who have agreed to participate in the research themselves,

Who cannot join

The refusal of caregivers or patients to participate in the study,
The caregiver ceases to provide care or the patient dies during the research,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hatay Mustafa Kemal University
Hatay

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Education Program Based on the Precede-Proceed Model to the Caregivers of Stroke Home Care Patients on Care Giving Response, Perceived Social Support Level, and Patient Outcomes.

Although stroke home care patients receive various treatments, they generally continue their lives as semi-dependent or fully dependent. Considering that stroke patients are especially elderly individuals, it is seen that they receive home health services and need a caregiver. The caregiver feels themselves under a heavy burden due to the lack of knowledge and insufficient experience. In addition, the lack of social support levels and the lack of training in patient care cause negative effects on patient outcomes.

Read the detailed description

The research will be carried out face-to-face with 70 stroke patients who receive health care from the home health services unit of a State Hospital and 70 individuals who care for these patients between July 2023 and December 2023. This study is a single-sample study with its own control group. During the implementation phase of the research, home visits will be made to the patients and training based on the Precede-Proceed model will be given to the individuals who care for the patients in the meeting room of the hospital where the research will be conducted. The collection of research data will take place in three stages. In the research, pre-education evaluation will be collected at the hospital before the training for the caregivers and home visits for the patients. In the second stage, the training program planned for the caregivers will be implemented in the meeting room of the hospital. After the training program reaches all of the caregivers in the determined number, the first evaluation will be made for the caregivers and the patient in the 8th week after the training is over. The third stage is the 16th week after the completion of the training, and the final evaluation will be made for the patients and caregivers. In the study, data will be collected using the individual caregiver personal information form, the caregiver response rating scale and the multidimensional perceived social support scale, and the patient personal information form for the patients. Statistical significance level will be accepted as p<0.05.

Conditions: Stroke
Being tested: Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients
Keywords: Stroke, Home Care Services, Caregivers, Social Support, Patient-Relevant Outcome
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patientsBehavioural
Home visits will be made to 70 stroke patients identified during the implementation phase of the research, and training based on the Precede-Proceed model will be given to 70 individuals who care for these patients in the meeting room of the hospital where the research will be conducted. In the research, pre-education evaluation will be collected at the hospital before the training for the caregivers and home visits for the patients. In the second stage, the training program planned for the caregivers will be implemented in the meeting room of the hospital. After the training program reaches all of the caregivers in the determined number, the first evaluation will be made for the caregivers and the patient in the 8th week after the training is over. The third stage is the 16th week after the completion of the training, and the final evaluation will be made for the patients and caregivers.

Study groups in NCT05901909
Study group	Role	What they receive
stroke home care patient	No intervention	Before applying the education program based on the Precede-Proceed Model to 70 individuals who care for stroke home care patients, the evaluation of the patients will be made with home visits. After the training is given to the caregivers, the first evaluation will be made at the 8th week in order to determine the change in patient results after the training is completed. In the 16th week after the completion of the training, a final evaluation will be made with home visits to determine the change in patient results.
Individuals caring for stroke home care patients	Experimental	Before the training program based on the Precede-Proceed Model is applied to the 70 individuals who care for stroke home care patients, the evaluation of the caregivers will be made in the hospital meeting room. After the training is given to the caregivers, the first evaluation will be made at the 8th week in order to determine the changes in their caregiving reactions and social support perceptions after the training is completed. In the 16th week after the completion of the training, a final evaluation will be made in the hospital meeting room in order to determine the changes in caregiver reactions and social support perceptions. Receives: Behavioral: Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient Evaluation Form
It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no
Measured: In the first week after the start of the study, home visits will be made and the patients will be evaluated through the patient evaluation form.
Patient Evaluation Form
It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no
Measured: After the training program reaches all of the caregivers in the determined number and the training is completed, the first evaluation will be made for the patient in the 8th week.
Patient Evaluation Form
It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no
Measured: It is the 16th week after the completion of the training, and the final evaluation will be made for the patients.

Secondary outcomes (6)

Caregiver Response Rating Scale
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Measured: The caregivers will be evaluated by using the Caregiver Response Evaluation Scale within the first week before the individuals who care for stroke home care patients are given training.
Caregiver Response Rating Scale
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Measured: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Caregiver Response Evaluation Scale at the end of the 8th week.
Caregiver Response Rating Scale
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Measured: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Caregiver Response Evaluation Scale at the end of the 16th week.
Multidimensional Scale of Perceived Social Support
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Measured: Individuals who care for stroke home care patients will be evaluated by using the Multidimensional Scale of Perceived Social Support in the first week without training.
Multidimensional Scale of Perceived Social Support
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Measured: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Multidimensional Scale of Perceived Social Support at the end of the 8th week.
Multidimensional Scale of Perceived Social Support
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Measured: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Multidimensional Scale of Perceived Social Support at the end of the 16th week.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 202318 Dec 2023

First posted13 Jun 2023
Study start13 Jul 2023
Primary completion18 Jul 2023
Study completion18 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: two groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05901909
Sponsor's protocol ID: HMKU-KMY-SA-01
Status last verified: Dec 2024
First submitted: 22 May 2023
Last updated: 11 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Akcoban S, Eskimez Z. Homecare patients' quality of life and the burden of family caregivers: a descriptive cross-sectional study. Home Health Care Serv Q. 2023 Jul-Sep;42(3):216-229. doi: 10.1080/01621424.2023.2177224. Epub 2023 Feb 12.
PubMed 36774648
Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.
PubMed 32324916
Sezgin D, Esin MN. Effects of a PRECEDE-PROCEED model based ergonomic risk management programme to reduce musculoskeletal symptoms of ICU nurses. Intensive Crit Care Nurs. 2018 Aug;47:89-97. doi: 10.1016/j.iccn.2018.02.007. Epub 2018 Mar 31.
PubMed 29609839
Akcoban S, Tosun B, Prosen M. Quasi-Experimental Study of Caregiver Training Using the PRECEDE-PROCEED Model for Stroke Home Care. Nurs Res. 2026 Mar-Apr 01;75(2):113-120. doi: 10.1097/NNR.0000000000000873. Epub 2025 Nov 17.
PubMed 41249088

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of the Education Program Based on the Precede-Proceed Model to the Caregivers of Stroke Home Care Patients on Care Giving Response, Perceived Social Support Level, and Patient Outcomes.
ClinicalTrials.gov ID: NCT05901909
Acronym / sponsor ID: HMKU-KMY-SA-01
Conditions: Stroke
Keywords: Stroke, Home Care Services, Caregivers, Social Support, Patient-Relevant Outcome
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Mustafa Kemal UniversityUniversity, hospital or other
Study start: 13 Jul 2023 (actual)
Primary completion: 18 Jul 2023 (actual)
Study completion: 18 Dec 2023 (actual)
First posted: 13 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: two groups

Arm	Type	Receives
stroke home care patient	No intervention	–Before applying the education program based on the Precede-Proceed Model to 70 individuals who care for stroke home care patients, the evaluation of the patients will be made with home visits. After the training is given to the caregivers, the first evaluation will be made at the 8th week in order to determine the change in patient results after the training is completed. In the 16th week after the completion of the training, a final evaluation will be made with home visits to determine the change in patient results.
Individuals caring for stroke home care patients	Experimental	Behavioral: Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patientsBefore the training program based on the Precede-Proceed Model is applied to the 70 individuals who care for stroke home care patients, the evaluation of the caregivers will be made in the hospital meeting room. After the training is given to the caregivers, the first evaluation will be made at the 8th week in order to determine the changes in their caregiving reactions and social support perceptions after the training is completed. In the 16th week after the completion of the training, a final evaluation will be made in the hospital meeting room in order to determine the changes in caregiver reactions and social support perceptions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Individuals who care for semi-dependent or fully dependent stroke home care patients who agree to participate in the study,
No communication problems,
Do not have any psychiatric disorders that will reduce the ability to comprehend and understand,
Caregivers over the age of 18.
Semi-dependent or fully dependent stroke home care patients,

Key exclusion criteria (2 listed)

The refusal of caregivers or patients to participate in the study,
The caregiver ceases to provide care or the patient dies during the research,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patientsHome visits will be made to 70 stroke patients identified during the implementation phase of the research, and training based on the Precede-Proceed model will be given to 70 individuals who care for these patients in the meeting room of the hospital where the research will be conducted. In the research, pre-education evaluation will be collected at the hospital before the training for the caregivers and home visits for the patients. In the second stage, the training program planned for the caregivers will be implemented in the meeting room of the hospital. After the training program reaches all of the caregivers in the determined number, the first evaluation will be made for the caregivers and the patient in the 8th week after the training is over. The third stage is the 16th week after the completion of the training, and the final evaluation will be made for the patients and caregivers.	Behavioural	Individuals caring for stroke home care patients

Primary outcome

Patient Evaluation Form
Time frame: In the first week after the start of the study, home visits will be made and the patients will be evaluated through the patient evaluation form.
It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no
Patient Evaluation Form
Time frame: After the training program reaches all of the caregivers in the determined number and the training is completed, the first evaluation will be made for the patient in the 8th week.
It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no
Patient Evaluation Form
Time frame: It is the 16th week after the completion of the training, and the final evaluation will be made for the patients.
It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no

6 secondary outcomes

Caregiver Response Rating Scale
Time frame: The caregivers will be evaluated by using the Caregiver Response Evaluation Scale within the first week before the individuals who care for stroke home care patients are given training.
Caregiver Response Rating Scale
Time frame: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Caregiver Response Evaluation Scale at the end of the 8th week.
Caregiver Response Rating Scale
Time frame: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Caregiver Response Evaluation Scale at the end of the 16th week.
Multidimensional Scale of Perceived Social Support
Time frame: Individuals who care for stroke home care patients will be evaluated by using the Multidimensional Scale of Perceived Social Support in the first week without training.
Multidimensional Scale of Perceived Social Support
Time frame: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Multidimensional Scale of Perceived Social Support at the end of the 8th week.
Multidimensional Scale of Perceived Social Support
Time frame: After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Multidimensional Scale of Perceived Social Support at the end of the 16th week.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Background: PubMed 36774648Akcoban S, Eskimez Z. Homecare patients' quality of life and the burden of family caregivers: a descriptive cross-sectional study. Home Health Care Serv Q. 2023 Jul-Sep;42(3):216-229. doi: 10.1080/01621424.2023.2177224. Epub 2023 Feb 12.
Background: PubMed 32324916Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.
Background: PubMed 29609839Sezgin D, Esin MN. Effects of a PRECEDE-PROCEED model based ergonomic risk management programme to reduce musculoskeletal symptoms of ICU nurses. Intensive Crit Care Nurs. 2018 Aug;47:89-97. doi: 10.1016/j.iccn.2018.02.007. Epub 2018 Mar 31.
Derived from this study: PubMed 41249088Akcoban S, Tosun B, Prosen M. Quasi-Experimental Study of Caregiver Training Using the PRECEDE-PROCEED Model for Stroke Home Care. Nurs Res. 2026 Mar-Apr 01;75(2):113-120. doi: 10.1097/NNR.0000000000000873. Epub 2025 Nov 17.
Individual participant dataSharing planned: No

Related trials for Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SÜMEYYE AKÇOBAN principal investigator

Mustafa Kemal University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Evaluation Form (time frame: In the first week after the start of the study, home visits will be made and the patients will be evaluated through the patient evaluation form.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901909, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.